MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Tissue Damage (2104); Vascular System (Circulation), Impaired (2572)

Event Date 11/13/2014

Event Type  Injury  

Manufacturer Narrative

No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device remained implanted; consequently, a direct product analysis was not possible.

Event Description

On (b)(6) 2014, a patient was implanted with a gore acuseal vascular graft in the left brachial artery to the axillary vein for arteriovenous access.The graft was cannulated on (b)(6) 2014.It was reported to gore that on (b)(6) 2014, the patient presented with severe arterial steal with tissue loss and the graft was ligated.A tunneled central venous catheter was implanted for arteriovenous access.On (b)(6) 2015, the patient expired due to an upper gi bleed.This is part of a data collection study from dr.(b)(6) using the gore acuseal vascular graft for arteriovenous access.

Manufacturer Narrative

Physician stated the event was not related to the graft itself, but was related to the patient's condition.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5217934
• MDR Text Key: 31001655
• Report Number: 2017233-2015-00777
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 49